QC Compliance Analyst

Simtra BioPharma Solutions•Bloomington, IN

3d•Onsite

About The Position

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. The QC Compliance Lead is responsible for overseeing quality compliance activities within the Quality Control organization, ensuring adherence to regulatory requirements, client expectations, and internal quality standards. This role provides compliance leadership, supports audits and inspections, drives continuous improvement initiatives, and serves as a key partner in managing quality and compliance risks across the QC function.

Requirements

Bachelor’s degree in a physical science required
Minimum of 5 years of experience in Quality
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Nice To Haves

Previous client/regulatory audit experience preferred.

Responsibilities

Acts as the QC Compliance lead
Provides guidance, support, direction and leadership for any quality compliance risks for the QC group.
Prioritizes workloads and assigns duties based on compliance risk.
Aids in client responses and CIs based on client findings
Participates in Client and Regulatory audits
Authors SOP revisions and any technical writing documents needed for CI completion
Performs review of regulatory changes and shifts in focus of regulatory agencies
Communicate with QC groups to determine plan for regulatory and client compliance